Protégé™ GPS™ SERB65-10-40-80 (UDI 00643169729056)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169729056), received between Apr 3, 2020 and Mar 2, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).

2 other recalls cover devices cleared under the same FDA submission (P060001); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2021Difficult to Open or Close

  LUMEN DEVICE DIDN'T OPEN UP AS SCRUB STAFF TESTED DEVICE ON STERILE FIELD. DEVICE DIDN'T REACHED PATIENT YET. A NEW STENT WAS OPENED AND USED FOR THE PROCEDURE. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404200 ↗
• MalfunctionApr 3, 2020Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  PHYSICIAN USED A PROTEGE GPS SELF-EXPANDING STENT SYSTEM DURING TREATMENT OF A SOFT TISSUE AV FISTULA. IFU WAS FOLLOWED. NO DAMAGE NOTED TO PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PRODUCT PACKAGING. THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS PERFORMED USING AN EVERCROSS PTA BALLOON. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE STENT WAS SUCCESSFULLY DEPLOYED WITHOUT ISSUE. FOLLOWING DEPLOYMENT, DIFFICULTY WAS ENCOUNTERED WHEN REMOVING THE DELIVERY SYSTEM. IT IS REPORTED THE CATHETER/DELIVERY SYSTEM DEFORMED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PROXIMAL HANDLE APPEARED TO SEPARATE FROM THE CATHETER HUB. THE DELIVERY CATHETER DID NOT CATCH ON THE STENT DURING REMOVAL ISSUE. NO INJURY TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9920044 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P060001. One submission often covers many models, so check the product and lot details in each record.

• Z-0879-2015 · Dec 4, 2014 · Terminated
  ev3, Protg Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterect
• Z-0878-2015 · Dec 4, 2014 · Terminated
  ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endartere